1. Field of the Invention
The present invention generally related to the field of data collection and processing. Specifically the invention relates to the areas of collecting a single set of data, capturing the data as a source document, processing the data into a variety of formats, and storing the various processed data records in discrete databases.
2. Description of Related Art
Currently, direct electronic data entry of patient information in clinical trials is rare except for some dedicated Phase 1 units. This is due to the fact that current electronic data capture systems, particularly those that are web-based, often fail to comply with the regulations pertaining to the capture and management of source documents as related to clinical trial data. Regulatory agencies, such as the FDA, require that clinical trial data be compiled in a source document, in order to verify the quality and integrity of the trial being conducted.
Electronic data capture tools are currently available which allow the user to collect clinical trial data. However, the clinical research sites still predominantly use paper source documents as the source data when the data are entered into the electronic data capture system. For instance, generally clinical research data are collected and recorded on a paper patient record form, and only later is the form transcribed into an electronic data capture system for clinical trial purposes. As a result, the clinical trial's case report form (CRF) is an abstraction of selected information from the patient record, not the patient record itself. This current industry practice necessitates substantial duplication of effort, and also creates potential for data inaccuracy. Furthermore, the review and processing of these paper records by regulatory agencies (such as the FDA) is a time-consuming and error-prone process.
Thus, there exists a significant need for a system capable of both electronic data capture with electronic source document capabilities. A system which provides such a range of functionalities will significantly enhance speed, efficiency and cost savings due to the elimination of transcription errors, source document verification and double-key data entry.